Berberis Vulgaris Consumption and Blood Pressure

Shahid Beheshti University

Status: Completed

Conditions: Lipid Profile; Cardiovascular Risk Factor; Blood Pressure

Treatments: Dietary Supplement: berberis vulgaris=barberry; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04084847

895 (Other Grant/Funding Number)

Details and patient eligibility

About

The aim of this study is to investigate the effect of barberry consumption on systolic and diastolic blood pressure, serum lipids, and inflammatory status. The study will involve cases having elevated BP (129/ < 85) and known hypertensive patients on medical treatment. Seventy people will be randomized into two groups, including intervention (barberry) or placebo groups.

Before and after of 8 week intervention, 24-hour ambulatory blood pressure monitoring will be done and fasting venous blood sample will be taken to measure plasma lipids. In addition, 24-hour urine will be collected to measure its sodium content and estimate sodium intake.

Enrollment: 78 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• willingness to participate in the study
• age between 20-65 years
• having elevated BP (129/ < 85) and known hypertensive patients on medical treatment
• at least one other classical cardiovascular disease risk factors, including hyperlipidemia or diabetes mellitus

Exclusion criteria

• Unwillingness to continue participation
• BMI> 30
• patients on nitrates
• high doses of statins consumption (Atorvastatin>40 mg/day or Rosuvastatin>20 mg/day)
• consumption of vitamins or minerals supplements during past month
• Chronic kidney disease stage 4 or 5

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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78 participants in 2 patient groups, including a placebo group

Barberry

Active Comparator group

Description:

Daily consumption of barberry in powder form.

Treatment:

Dietary Supplement: berberis vulgaris=barberry

placebo

Placebo Comparator group

Description:

Daily consumption of placebo powder.

Treatment:

Dietary Supplement: Placebo